Appendix: Quality Assurance Guidelines for Testing Using the OraQuick 

Rapid HIV-1 Antibody Test 

Overview This appendix includes several items to facilitate conducting testing and 

performing quality assurance using the OraQuick Rapid HIV-1 Antibody test. 

The forms provided are examples and templates that can be adapted for local use, 

adding or deleting fields, as needed. The appendix includes the following: 

A. Government regulations

B. Example training checklist for the OraQuick Rapid HIV-1 Antibody Test 

C. Example of a temperature log 

D. Example log of quality control results 

E. Example log of test results 

F. Example specimen transfer log 

G. External assessment: proficiency testing and other mailed evaluation 

programs 

Appendix to the QA Guidelines for OraQuick 1 
Appendix to the QA Guidelines for OraQuick 2 











Appendix A

Government Regulations 

Food and Drug

Administration

(FDA) sales 

restrictions

To help ensure the quality of testing with the OraQuick test, the FDA approved

the test kit it with specific restrictions for its sale. These restrictions apply to the

waived test kit. By purchasing the test, the customer agrees to follow these 

restrictions. The restrictions are outlined below (for the specific FDA language,

refer to the OraQuick package insert). The kit purchaser must:

Be a clinical laboratory, i.e., holds a certificate from the Federal government

(Clinical Laboratory Improvement Act of 1988 (CLIA) certificate – see below

for details) and any state or other certification that is required.

Have an established quality assurance program.

Provide training for testing personnel (operators) using the instructional 

materials provided by the manufacturer.

Provide information to persons being tested by giving each a copy of the

manufacturer’s “Subject Information” pamphlet prior to specimen collection

and appropriate information when providing the test results.

Not use the kit to screen blood or tissue donors.

Clinical

Laboratory 

Improvement

Amendment 

(CLIA) regulations 

The OraQuick test is a waived test under Federal regulations—the regulations for

the Clinical Laboratory Improvement Amendments of 1988 (CLIA regulations). 

As a waived test, Federal requirements for the OraQuick test are minimal. The 

CLIA requirements for sites wishing to offer testing using the OraQuick test are

listed below and can be found at http://www.phppo.cdc.gov/clia/regs/toc.asp.

Each site must:









Have a valid CLIA certificate of waiver, certificate of compliance or 

certificate of accreditation.

Follow the manufacturer’s instructions for performing the test, and 

Permit announced or unannounced inspections by representatives of the 

Centers for Medicare & Medicaid Services (CMS) under certain 

circumstances (see §493.35(d) in the regulations at the Web site listed above).

Perform only waived tests if holding a certificate of waiver.
Appendix to the QA Guidelines for OraQuick 3 

Government Regulations (continued) 

How to obtain a

CLIA certificate

All sites planning to offer only the OraQuick test that are not already CLIA

certified, must obtain a Certificate of Waiver or be included under a multiple site

exception, such as limited public health testing or mobile testing. To obtain a 

Certificate of Waiver, complete Form CMS-116, found at the following CMS 

Internet address: http://www.cms.gov/clia/cliaapp.asp. This form asks for 

information on the facility type (select from a list), hours of operation, estimated 

annual number of waived tests to be performed, the type of control (nonprofit, for 

profit or government control) and the total number of individuals involved in

performing testing. The facility owner or laboratory director must sign the form.

Mail the completed form to the State agency in which your site is located. To find

your State agency contact, refer to the information provided at the following 

Internet address http://www.cms.gov/clia/ssa-map.asp. After the completed form

is processed by the State agency, a fee of $150 will be assessed for a Certificate of

Waiver. The certificate is valid for two years.

State regulations In addition to CLIA, some States have specific regulatory requirements for HIV

testing. Contact your State agency for information on State requirements. State

agency contacts are listed at http://www.cms.gov/clia/ssa-map.asp.

Occupational safety

and health 

regulations 

Employers with employees who have an occupational exposure to blood or other 

potentially infectious materials must meet the U.S. Department of Labor 

Occupational Health and Safety Administration (OSHA) standards for bloodborne 

pathogens. Individuals collecting blood specimens or performing the OraQuick 

test have exposure to blood or other potentially infectious materials resulting from

the performance of their duties. Therefore, sites offering the OraQuick test must

meet OSHA standards that include, but are not limited to, the following

requirements:





Have a written Exposure Control Plan.

Provide personal protective equipment, such as gloves. 

Make available the hepatitis B vaccine and vaccination series to all employees 

who have occupational exposure.

Provide post-exposure evaluation and follow-up to all employees who have 

had an exposure incident.

 Provide training for all employees with occupational exposure.

 Contain and dispose of biohazard waste following applicable regulations

(includes blood and items contaminated with blood or other potentially

infectious materials). Refer to state and local regulations regarding disposal

of biohazardous materials.

NOTE: This is an overview of OSHA requirements and is not a complete list. 

For specific information, visit the OSHA Web site at

http://www.osha.gov/SLTC/bloodbornepathogens/index.html. 




Appendix to the QA Guidelines for OraQuick 4 

Appendix B

Example Training Checklist for the OraQuick Rapid HIV-1 Antibody Test 

Employee: Name_________________________

Instructions: Fill in dates when the trainee observes and performs each objective or procedural step, as

applicable. (If a trainee will not perform a specific task, enter N/A for not applicable.) The trainee should 

initial when he/she feels the objective/procedure has been mastered and the trainer when he/she thinks the

trainee has met the objective or performs the specific procedure competently.

Objective/Procedural Step Date

Observed 

Date

Performed 

Trainee’s

initial and

date

Trainer’s

initial and 

date

Read OraQuick procedure N/A 

Read Biohazard Exposure Control Plan N/A 

Determine if requirements for acceptable 

testing environment are met (e.g., 

temperature, lighting, level work space)

 

Practice test with negative and positive

external controls

 

Give person getting tested the “Subject

Information” brochure

 

Label test device components and 

appropriate paperwork

 

Collect finger-stick specimen, put loop 

into vial and mix correctly

 

Insert test device, time test, read result

Dispose of lancet and other biohazardous

waste appropriately

Record results on report form and log 

sheet

 

Record internal and external quality

control (QC) results in QC log

 

Evaluate a new OraQuick test kit lot

number and record results in QC log

 

Report test result to the person being

tested (one negative and one preliminary 

positive)

 

Refer person or collect specimen for 

confirmatory testing

 

Send confirmatory test specimen to 

referral laboratory and document

submission

 

Receive referral laboratory results and 

record results

 

Explain what to do if QC results show a 

problem

 
Appendix to the QA Guidelines for OraQuick 5 

Appendix C

Example Temperature Log 

Thermometer location ________________________________ 

Acceptable temperature range* _________________________ 

Month/Year ___________________ 

Day Temperature Initials Day Temperature Initials 

1 17 

2 18 

3 19 

4 20 

5 21 

6 22 

7 23 

8 24 

9 25 

10 26 

11 27 

12 28 

13 29 

14 30 

15 31 

16 

*The acceptable range for test kit storage is 2o to 27o C or 35o to 80o F; the acceptable range for control kit

storage is 2o to 8o

C or 35o to 46o F; the acceptable range for the testing area is 15o to 27o C or 59o to 80o F.

NOTE: Periodically (e.g., every six months) check thermometer performance and document.

Corrective Action

Date Action Taken Initials 

Reviewed by and date ________________________________________________________________
Appendix D 

Example Log of Control Results 

Date Time Test Kit Lot 

# 

Test 

Kit 

Exp. 

Date* 

New

Lot #,

shipment ? 

Control Kit

Lot #

Control 

Kit Exp. 

Date 

Date 

controls 

opened

Negative 

Control 

Result 

Positive Control 

Result 

Results

Acceptable? 

*Exp. = Expiration Corrective Action (use reverse side, if needed) Date Action Taken Initials RAppendix to the QA Guidelines for OraQuick 6 
Appendix E 

Example Log of Test Results

Confirmatory Testin

Test 

Subject 

ID* 

Date and 

Time 

Specimen 

Collected

Kit Lot 

Number

Kit 

Expiration

Date 

Actual 

Test 

Incubation

Time 

Test result 

N=nonreactive R=reactiveI=invalid 

Tester Result

and

Time 

Reported

to

Subject 

Tracking # Specimen type

(blood or

oral

fluid) 

Result D

re

rece

*ID = IdentificationAppendix to the QA Guidelines for OraQuick 7 
Appendix F 

Example Specimen Transfer Log 

[Put Referring Facility Name, 

Address and Phone Number here] 

Date:_______________________ 

Referral Laboratory _________________________________ 

Specimen 

Tracking

Number 

Test 

Subject 

ID* 

OraQuick 

Test Result 

Date 

Specimen 

Collected

Time 

Specimen 

Collected

Collected

by 

Referral 

Lab Req†

Completed

(9) 

Date Conf 

Result 

Received

Confirm 

Test 

Result 

*ID = Identification

†

Lab Req = Laboratory Requisition

(NOTE: If you use more than one referral laboratory, add a column to record each one.) 

Appendix to the QA Guidelines for OraQuick 8 
Appendix G 

External Assessment: Proficiency Testing and Other Mailed Evaluation 

Programs

Background and 

overview 

Some States may require participation in a State or Centers for Medicare & 

Medicaid Services (CMS)-approved proficiency testing program, even though this 

program is not required by CLIA for waived tests. Participating in proficiency

testing or an external evaluation program is a relatively easy way to obtain an 

external assessment of the quality of waived testing. There are several programs

in which a site may choose to enroll. Test samples will be received by mail on a 

periodic basis, usually two to three times per year. These samples include a 

combination of several (typically five) HIV antibody positive and negative 

specimens with results known to the program provider, but not to the participants. 

The participants test the samples as if they were client/patient specimens and send 

results back to the program provider. 

Evaluation reports In proficiency testing programs, the results from the individual participant sites 

are compared to the expected values. Each site receives a graded individualized 

report and summary report showing their performance and the performance of all 

the participants. In some evaluation programs, such as the Model Performance

Evaluation Program (MPEP) offered by the Centers for Disease Control and 

Prevention (CDC), individual participant results are not graded; instead a 

summary report is provided with a compilation of results from all participants and 

a commentary on overall performance.

For more 

information 

For more information, refer to the following Internet sites: 

 The CDC MPEP for rapid HIV testing can accommodate a limited number of 

additional sites. For more information and to enroll on-line go to the 

following Web sites: http://www.phppo.cdc.gov/mpep/default.asp, 

http://www.phppo.cdc.gov/mpep/enrollment.asp. There is currently no fee to 

enroll in the MPEP program. 

 For a list of CLIA approved proficiency testing programs (several of which 

include HIV testing) go to http://www.cms.gov/clia/ptlist.pdf. This list 

includes contact information for each program and the tests offered. These 

programs charge an enrollment fee. 

Appendix to OraQuick QA Guidelines 9